1. The Field of the Invention
The invention relates to treatment compositions and methods for treatment of disordered tissues, such as those caused by a virus, fungus, or bacteria.
2. The Relevant Technology
Tissue disorders caused by pathogens, particularly those which impact epithelial tissue and are caused by the Herpes virus, such as Herpes Simplex Types I and II and Herpes Zoster (shingles), cold sores, genital herpes, or, candida albicans, chicken pox, acne, psoriasis, eczema, seborrhea, and dermatitis, are common but often difficult to treat. Herpes simplex virus (HSV-I and HSV-II) and Herpes Varicella-Zoster (chicken pox, shingles), commonly referred to as herpes virus or herpes, is an infectious disease which has reached crisis proportions nationally with estimated numbers of infected people at 70%-80% of U.S. population as reported by the American Social Health Association (ASHA). Other literature sources put the number of infected Americans at 85%-90% of the adult population.
Herpes virus enters the human body through minuscule breaks in the epidermal tissue, usually by contact with an infected host, and is marked by eruption of one or more vesicles, usually in groups, following an incubation period of approximately two to ten days. Typically, the course of the infectious outbreak initiates with the prodromal stage, advancing to vesicular eruption, followed by ulceration, coalescing, resolution by formation of scab, and the latency period. The outbreak can last for several weeks and, on average, lasts one to three weeks. In some immune compromised individuals, the outbreak can last for months. The vesicles can appear anywhere on epithelial tissues including the skin or mucosa, typically appearing on the lips as cold sores, glands, and oral mucosa. More severe cases may involve the conjunctiva and cornea. Genital herpes may involve the genitalia, anal mucosa and peri-anal tissue.
Herpes symptoms include inguinal swelling, pain, fever, malaise, headaches, muscle aches, and swollen glands. During latency, the virus lies dormant in the trigeminal nerve ganglia. Some individuals with oral herpes have excruciating facial pain, difficulty swallowing, eating and facial swelling. Individuals with the herpes that impacts the sacral nerve (genital herpes) have pain in the genital area, upper leg pain, swelling, and on occasion great difficulty walking.
Herpes simplex virus (HSV) infection, whether oral or genital, is recurring, residing in the nerve ganglia, then recurring due to some, as yet unknown, mechanism. Recurrent herpetic infections can be precipitated by numerous stimuli, including exposure to sunlight, nutritional deficiencies, stress, menstruation, immunosuppression, certain foods, drugs, and febrile illness.
Herpes infections can pose serious health threats, often causing blindness if the virus infects the cornea, increased cancer risk of the cervix, aseptic meningitis and encephalitis, neonatal deaths, viremia, the spread of the human immunodeficiency virus (HIV), etc. The devastating effects of this disease go well beyond the medical scope of human suffering. HSV can be responsible for serious psychological and emotional distress as well as substantial economic loss. Individuals with Auto Immune Deficiency Syndrome (AIDS) are seriously immune-compromised and can suffer especially debilitating outbreaks of HSV.
Various treatments for herpes have been proposed and include topical application of such agents as povidone-iodine, idoxuridine, trifluorothyidine, or acyclovir and its analogs. Such treatments have met with varying degrees of success. Most treatments have proven disappointing. Acyclovir and similar analogs, acyclic nucleosides, are taken orally for systemic treatment of HSV or they are applied topically. Acyclovir is somewhat effective in inhibiting the activity of several herpes viruses. However, acyclovir is only successful in interrupting the replication of the virus and is used to treat infectious outbreak systemically. Denavir is the topical version of an acyclovir analog. Few topical treatments have proven to be effective and all nucleoside treatments must be applied at first signs and symptoms of disease to achieve maximum effectiveness.
Biologically active antiviral and antimicrobial compositions have been met with marginal success when administered topically for tissue disorders. Such compositions have been applied as gels, creams, lotions, oils, ointments, pastes, tinctures, emulsions, and colloidal suspensions. Most of the compositions are oil-based to ensure the composition has sufficient viscosity and/or tackiness to remain on the surface of the skin without being rubbed off. In fact, such compositions are often absorbed into clothing more than into the skin due to a relatively slow epidermal penetration rate. Even when sufficient time is allowed for the compositions to penetrate, they are often not sufficiently effective in treating the disordered tissue and must generally be applied repeatedly over a period of days or even weeks.
Many efforts have been undertaken to remedy the inadequacies of topically administered compositions. The therapeutic effects of such compositions depend upon the specific active agent and the method of application. Many compositions contain ingredients that may provide symptomatic relief of pain and itching but are not claimed to be effective against Herpes infection except drugs based on acyclovir technology, which are purported to have some topical efficacy. Most compositions intended to treat such disorders do not effectively treat the discomfort and the disease symptoms, let alone cure the disorder or put it into a significant remission.
One useful treatment composition, sold under the name Viroxyn®, has been effective in providing relief for cold sores. Viroxyn® is covered by one or more of the following U.S. Pat. Nos. 6,759,434; 6,423,750; 6,420,431; 6,414,032; 6,410,599; and 6,211,243, the disclosures of which are incorporated herein by reference. When used as instructed, which includes using a specifically designed applicator to vigorously rub or burnish the composition into the cold sore, Viroxyn can be effective in reducing the healing time of a cold sore. Vigorous rubbing is required to force the composition to penetrate into the cold sore to a depth sufficient to kill the viruses causing the infection.
An example of a less useful composition and treatment method is provided in U.S. Pat. No. 5,753,270 to Beauchamp et al. This patent discloses a composition that includes: (a) an antiseptic and/or anesthetic compound which is (i) a terpene, such as menthol or eucalyptol or (ii) a phenolic compound, such as thymol; (b) a quaternary ammonium antiseptic compound, such as benzethonium chloride; and (c) an antiseptic compound containing iodine, salts thereof and/or complexes thereof dissolved in an organic solvent, such as a mixture of water and acetone. The composition requires application to the afflicted area in a sequence that includes 3 to 4 applications over a one minute period, which is then repeated every 3 minutes over a 10 minute period. The entire procedure is then repeated every ½ to 1 hour for 2 to 3 hours or until activity is stopped and healing is evident. The composition must therefore be applied many times over an extended period of time to be effective, which greatly diminishes compliance and effectiveness.